The world’s first chimeric antigen receptor T cell (CAR-T) treatment’Kimria’ has been approved in Korea.
The Ministry of Food and Drug Safety announced on the 5th that it has approved’Kimriaju (Tisagen Lexucell)’, which Novartis Korea has applied for permission, as the first advanced biopharmaceutical under the Advanced Regenerative Bio Act.
CAR-T is a gene that combines a receptor site of immune cells (T cells) with a characteristic antigen recognition site on the surface of cancer cells into a patient’s T cells. It has the function of specifically recognizing and attacking the surface antigens of cancer cells.
Kimria is an anticancer drug in which genetic information is introduced into the patient’s body so that specific antigens of cancer cells can be recognized on the surface of immune cells collected from patients.
It is explained that even a single administration showed improved efficacy in patients with relapsed and refractory hematologic cancer. In the US, it was designated as a breakthrough designation and in Europe, it was designated as a priority drug (PRIME) and approved.
The Ministry of Food and Drug Safety completed the review and evaluation of quality, safety and effectiveness, post-marketing safety management plan, etc. according to the review criteria. The Central Pharmacy Review Committee consulted on the validity of the permit and the conformity of the system.
Kimlia is a drug subject to’long-term follow-up investigation’ pursuant to Article 30 of the Advanced Regenerative Bio Act, and the status of abnormal cases must be followed for 15 years from the date of administration. In addition, the contents and results of long-term follow-up surveys must be reported to the Ministry of Food and Drug Safety every year from the date of initial sale.
An official from the Ministry of Food and Drug Safety said, “The approval of this product is expected to provide new treatment opportunities for patients with recurrent and refractory hematologic cancer who do not have alternative drugs or for whom standard treatment methods have not been established.” We will safely manage the steps after use.”
Reporter Kim Ye-na [email protected]
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